Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry(2)

Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Ma...

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Detalles Bibliográficos
Autores: Cruz-Gonzalez, I, Saura, FT, Trejo-Velasco, B, Diaz, JAF, Molina, RF, Del Valle-Fernandez, R, Terribas, GM, Sanchez, DM, Lopez-Minguez, JR, Gomez-Blazquez, I, Pena, JCS, Botas, J, Lorenzo, PM, Palazuelos, J, Rincon, RA, Mohandes, M, Entem, FJR, Marti, G, Valero, E, Gutierrez, H, Amat-Santos, IJ, Nombela-Franco, L, Salinas, P, Teruel, L, Gomez-Hospital, JA, Arzamendi, D, Sanabria, MT, Perez, GC, Pruano, DC, de Prado, AP, Gonzalez, TB, Arroyo-Ucar, E, Estevez-Loureiro, R, Caneiro-Queija, B, Criado, JLI, Ruiz-Nodar, JM
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p7550
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones7550
Access Level:acceso abierto
Palabra clave:Atrial fibrillation
Left atrial appendage occlusion
Devices
Outcomes
Descripción
Sumario:Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed <= 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA(2)DS(2)-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the center's previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operator's experience with its previous device iteration or the number of Watchman FLX devices implanted.

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